BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX BILIARY

    MDR report key: 25247452 · Received May 21, 2026

    Report

    Report Number
    3005099803-2026-02017
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    January 1, 2010
    Report Date
    May 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PNB
    PMA / PMN Number
    K240464
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED BETWEEN JANUARY 1, 2010 AND JANUARY 1, 2023. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE UPN AND LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK E1: INITIAL REPORTER CITY: CLERMONT-FERRAND, AUVERGNE-RHONE-ALPES; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G2: LITERATURE SOURCE: THOMAS GUILMOTEAU, ET AL. DIRECT COMPARISON OF SIMULTANEOUS AND SEQUENTIAL ENDOSCOPIC METALLIC BILATERAL STENTING IN MALIGNANT HILAR BILIARY OBSTRUCTION. WORLD J GASTROENTEROL 2025 MAY 21; 31(19): 101913. DOI: 10.3748/WJG. V31.I19.101913. BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE. IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF ADMISSION TO THE INTENSIVE CARE UNIT.

    Description of Event or Problem · 0

    PROCEDURE SUMMARY BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING A WALLFLEX BILIARY STENTS THROUGH THE ARTICLE "DIRECT COMPARISON OF SIMULTANEOUS AND SEQUENTIAL ENDOSCOPIC METALLIC BILATERAL STENTING IN MALIGNANT HILAR BILIARY OBSTRUCTION" BY THOMAS GUILMOTEAU, ET AL. EVENT SUMMARY: THIS RETROSPECTIVE STUDY FOCUSED ON THE DIFFERENT DRAINAGE TECHNIQUES USING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR MALIGNANT HILAR BILIARY OBSTRUCTION. ALL PATIENTS WHO UNDERWENT BILATERAL BILIARY METALLIC STENTING DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR MHBO IN CLERMONT-FERRAND UNIVERSITY HOSPITAL BETWEEN JANUARY 1, 2010 AND JANUARY 1, 2023. CONVENTIONAL SEQUENTIAL SBS PLACEMENT WAS PERFORMED AT OUR INSTITUTION BETWEEN 2010 AND 2017. SINCE 2017, SIMULTANEOUS SBS PLACEMENT HAS BEEN PERFORMED ON PATIENTS WITH UNRESECTABLE MHBOS REQUIRING BILATERAL DRAINAGE. THE PATIENT COHORT WAS DIVIDED INTO THOSE WHO UNDERWENT SEQUENTIAL SBS OR SIS PLACEMENT BETWEEN 2010 AND 2017 (SEQUENTIAL GROUP) AND THOSE WHO UNDERWENT SIMULTANEOUS SBS PLACEMENT BETWEEN 2017 AND 2023 (SIMULTANEOUS GROUP). THE TWO GROUPS WERE COMPARED RETROSPECTIVELY. THE ARTICLE REPORTED PROCEDURAL DETAILS AND OUTCOMES FOLLOWING THE SEQUENTIAL SBS TECHNIQUE. ADVERSE EVENTS INCLUDED PANCREATITIS IN FOUR PATIENTS (NO INTENSIVE CARE UNIT ADMISSION OR ENDOSCOPIC/SURGICAL INTERVENTION REQUIRED), CHOLANGITIS IN SIX PATIENTS (TWO REQUIRING INTENSIVE CARE UNIT ADMISSION), MEDICALLY MANAGED HEMORRHAGE IN ONE PATIENT, AND SURGICALLY MANAGED RECURRENT BILIARY OBSTRUCTION IN ONE PATIENT. PLEASE REFER TO THE REFERENCED ARTICLE FOR FULL DETAILS, DATA ANALYSIS, AND LIST OF PARTICIPATING INVESTIGATORS AND INSTITUTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559203 WALLFLEX BILIARY BILIARY STENT SYSTEM FOR BENIGN STRICTURES PNB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1